GADOVERSETAMIDE - Generic Drug Details
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What are the generic sources for gadoversetamide and what is the scope of freedom to operate?
Gadoversetamide
is the generic ingredient in two branded drugs marketed by Liebel-flarsheim and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for gadoversetamide.
Summary for GADOVERSETAMIDE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 3 |
| Drug Master File Entries: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,042 |
| DailyMed Link: | GADOVERSETAMIDE at DailyMed |
Recent Clinical Trials for GADOVERSETAMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Astellas Pharma US, Inc. | N/A |
| Daniel S. Berman | N/A |
| Guerbet | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for GADOVERSETAMIDE
US Patents and Regulatory Information for GADOVERSETAMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Liebel-flarsheim | OPTIMARK | gadoversetamide | INJECTABLE;INJECTION | 020975-001 | Dec 8, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Liebel-flarsheim | OPTIMARK | gadoversetamide | INJECTABLE;INJECTION | 020937-004 | Dec 8, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Liebel-flarsheim | OPTIMARK | gadoversetamide | INJECTABLE;INJECTION | 020937-003 | Dec 8, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Liebel-flarsheim | OPTIMARK | gadoversetamide | INJECTABLE;INJECTION | 020937-002 | Dec 8, 1999 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for GADOVERSETAMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Liebel-flarsheim | OPTIMARK | gadoversetamide | INJECTABLE;INJECTION | 020937-001 | Dec 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Liebel-flarsheim | OPTIMARK IN PLASTIC CONTAINER | gadoversetamide | INJECTABLE;INJECTION | 020976-001 | Dec 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Liebel-flarsheim | OPTIMARK | gadoversetamide | INJECTABLE;INJECTION | 020975-001 | Dec 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Liebel-flarsheim | OPTIMARK IN PLASTIC CONTAINER | gadoversetamide | INJECTABLE;INJECTION | 020976-001 | Dec 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for GADOVERSETAMIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Mallinckrodt Deutschland GmbH | Optimark | gadoversetamide | EMEA/H/C/000745 This medicinal product is for diagnostic use only.Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology. |
Withdrawn | no | no | no | 2007-07-23 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
